87083-004

87083-004
SPL v1
SPL
SPL Set ID 41bbc02c-53f2-2d94-e063-6394a90ac9ec
Route
TOPICAL
Published
Effective Date 2025-10-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (1 g)
Inactive Ingredients
Alcohol Polysorbate 20 Polyoxyl 40 Hydrogenated Castor Oil Caramel Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-22

Description

Tolnaftate 1%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Tolnaftate 1%

Use

Cures most Athlete's Foot (Tinea Pedis) and Ringworm (Tinea Corporis). Relieves itching, scaling, cracking, burning. redness, soreness, and Irri tation and discomfort.Helps prevent most athlete's foot (dermatophytos is) with daily use.

Stop Use

Irritation occurs, there is no Improvement with in 4 weeks (for athlete's foot and ringworm).If irritation occurs, discontinue use and consult a doctor.

Warnings

For external use only.

Ask Doctor

If irritation occurs, discontinue use and consult a doctor.

Directions

For athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks.

Clean the affected area and dry thoroughly. Apply a thin layer of the product to the feet once or twice daily.Supervise child ren in the

use of this product. This product is not effective for the treatment of ring worm of the

scalp or nails. For athlete's foot: pay special attention to spaces between the toes, wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.

To clean athlete's foot, apply once or twice daily (morning and/or night). Apply to skin aroundthe nail and cuticle.Supervise children in the use of this product. If condition persists longer, consult a doctor. This product is not effective on the scalp or nails. To clean athlete's foot the feet and dry thoroughly.

Do Not Use

Do not use on Children under 2 years of age unless directed by a doctor.

When Using

When using this product avoid contact with eyes.

Active Ingredient



Tolnaftate 1%

Other Information

Store at room temperature 15-30℃(59-86℉)

Inactive Ingredients

Ethanol, water, PEG-40 hydrogenated castor oil Caramel color, Polysorbate -20

Principal Display Panel

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Use

Cures most Athlete's Foot (Tinea Pedis) and Ringworm (Tinea Corporis). Relieves itching, scaling, cracking, burning. redness, soreness, and Irri tation and discomfort.Helps prevent most athlete's foot (dermatophytos is) with daily use.

Purpose

Antifungal

Stop Use

Irritation occurs, there is no Improvement with in 4 weeks (for athlete's foot and ringworm).If irritation occurs, discontinue use and consult a doctor.

Warnings

For external use only.

Ask Doctor

If irritation occurs, discontinue use and consult a doctor.

Directions

For athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks.

Clean the affected area and dry thoroughly. Apply a thin layer of the product to the feet once or twice daily.Supervise child ren in the

use of this product. This product is not effective for the treatment of ring worm of the

scalp or nails. For athlete's foot: pay special attention to spaces between the toes, wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.

To clean athlete's foot, apply once or twice daily (morning and/or night). Apply to skin aroundthe nail and cuticle.Supervise children in the use of this product. If condition persists longer, consult a doctor. This product is not effective on the scalp or nails. To clean athlete's foot the feet and dry thoroughly.

Do Not Use (Do not use)

Do not use on Children under 2 years of age unless directed by a doctor.

When Using

When using this product avoid contact with eyes.

Active Ingredient



Tolnaftate 1%

Other Information (Other information)

Store at room temperature 15-30℃(59-86℉)

Inactive Ingredients (Inactive ingredients)

Ethanol, water, PEG-40 hydrogenated castor oil Caramel color, Polysorbate -20

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Out of Reach of Children (Keep Out Of Reach Of Children)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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